Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02004522 · BASELINE

Baseline characteristics

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) · Source last updated 2023-09-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      160
    2. group Id
      BG001
      value
      159
    3. group Id
      BG002
      value
      319
    units
    Participants
groups
  1. description
    Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
    id
    BG000
    title
    Duvelisib
  2. description
    Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
    id
    BG001
    title
    Ofatumumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          102
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          217
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          191
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          263
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          41
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          292
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      New Zealand
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
      title
      Austria
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
      title
      Belgium
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          65
      title
      Hungary
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          51
      title
      United States
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          41
      title
      Italy
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          17
      title
      United Kingdom
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
      title
      Australia
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          30
      title
      France
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Germany
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          40
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      160
    2. group Id
      BG001
      value
      159
    3. group Id
      BG002
      value
      319
    units
    Participants
groups
  1. description
    Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
    id
    BG000
    title
    Duvelisib
  2. description
    Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
    id
    BG001
    title
    Ofatumumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          102
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          217
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          128
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          96
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          191
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          130
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          263
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          41
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          292
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      New Zealand
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
      title
      Austria
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          27
      title
      Belgium
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          65
      title
      Hungary
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          51
      title
      United States
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          41
      title
      Italy
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          17
      title
      United Kingdom
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          21
      title
      Australia
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          30
      title
      France
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Germany
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          40
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice